Actualités réglementaires2 sept. 2026•1 min de lecture

Stryker LP35 Defibrillator Display Issue Identified

Par l'équipe PharmaCountry

Stryker reports the LP35 may not display the "CHECK RHYTHM / ECG Analysis Inconclusive" message under certain conditions, while shock advisories and therapy remain functional.

Stryker has identified an issue with the LP35 where the device does not display the message "CHECK RHYTHM / ECG Analysis Inconclusive" as intended when specific conditions are present simultaneously. The issue does not affect the display of "shock advised" or "no shock advised" messages, and therapy delivery remains available. Additionally, this nonconformance is limited to the device on-screen prompts only; rhythm analysis is not impacted by this issue.

Compilé par l'équipe PharmaCountry · Source : Health Canada

Sujets :#defibrillator #monitor #Stryker #cardiac rhythm #medical devices